OsteosarcomaNCT04571229
Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma
A study testing L-MTP-PE in people with Osteosarcoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This expanded access protocol will allow access to treatment with L-MTP-PE for people with osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by the FDA to treat any condition, including osteosarcoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- L-MTP-PE
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newly diagnosed or relapsed osteosarcoma are eligible.
- Surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma
- L-MTP-PE is deemed to be of potential benefit by the treating investigator
- Willing and able to understand and sign informed consent and assent as appropriate
- Life expectancy > 6 weeks
- Adequate organ function as follows:
Show all 17Show fewer
- Adequate bone marrow function defined as:
- absolute neutrophil count (ANC) ≥ 750/mm^3
- platelet count ≥ 30,000/ mm^3
- hemoglobin ≥ 8 g/dl
- Adequate renal function defined as:
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min/1.73m^2 OR
- Serum creatinine ≤ 2x the upper limit of normal based on age/gender
- Adequate liver function defined as:
- Bilirubin (sum of conjugated + unconjugated) ≤ 2x upper limit of normal for age or ≤ 4x upper limit of normal if thought to have Gilbert's disease
- AST or ALT ≤ 3x upper limit of normal or ≤ 5x upper limit of normal for patients with liver metastases
- Willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant
Who cannot join
- Use of chronic steroids of other immunosuppressive agents
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
Paul Meyers, MD contact
United States1 site
- Available
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Emily Slotkin, MD, 212-639-8856
Paul Meyers, MD, 212-639-5952
About this study
This expanded access protocol will allow access to treatment with L-MTP-PE for people with osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by the FDA to treat any condition, including osteosarcoma. L-MTP-PE works by activating certain types of white blood cells, and these active white blood cells help the immune system kill cancer cells.
- Conditions
- Osteosarcoma
- Being tested
- L-MTP-PE
- Keywords
- L-MTP-PE, Expanded Access, 20-324
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-MTP-PEDrug
L-MTP-PE will be administered at a dose of 2mg/m2 (maximum dose 4 mg), twice weekly for 12 weeks and weekly for an additional 24 weeks, for a total of 48 doses in 36 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Slotkin, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571229
- Sponsor's protocol ID
- 20-324
- Status last verified
- May 2026
- First submitted
- 16 Sep 2020
- Last updated
- 11 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma
- ClinicalTrials.gov ID
- NCT04571229
- Acronym / sponsor ID
- 20-324
- Conditions
- Osteosarcoma
- Keywords
- L-MTP-PE, Expanded Access, 20-324
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This expanded access protocol will allow access to treatment with L-MTP-PE for people with osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by the FDA to treat any condition, including osteosarcoma. L-MTP-PE works by activating certain types of white blood cells, and these active white blood cells help the immune system kill cancer cells.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newly diagnosed or relapsed osteosarcoma are eligible.
- Surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma
- L-MTP-PE is deemed to be of potential benefit by the treating investigator
- Willing and able to understand and sign informed consent and assent as appropriate
- Life expectancy > 6 weeks
Key exclusion criteria (2 listed)
- Use of chronic steroids of other immunosuppressive agents
- Pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-MTP-PEL-MTP-PE will be administered at a dose of 2mg/m2 (maximum dose 4 mg), twice weekly for 12 weeks and weekly for an additional 24 weeks, for a total of 48 doses in 36 weeks. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Meyers, MD contact
Emily Slotkin, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-MTP-PE in people with Osteosarcoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily Slotkin, MD (212-639-8856, slotkine@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.